The present invention relates in general to autoclave trays, cases and enclosures wherein various holders, brackets, racks and clamps are used to secure and retain a variety of surgical and/or dental components, instruments and related medical apparata. More specifically the present invention relates to the selective and arbitrary customizing of holders for such components, instruments and related apparata as well as the selective arranging of the holders into the receiving tray.
Within the field of autoclave trays, cases and enclosures there are numerous design approaches which have been used over the years to try and receive and secure in place the particular items which need to be sterilized. One category of design approach involves the use of separate racks which actually receive the items and these racks are then positioned in some type of tray or enclosure for the purposes of storage and sterilizing. On occasion the lid portion of the case or enclosure is used to clamp down on the items or onto the rack or both as the means to keep the items stationary and not allow them to move around or shift in position during handling and autoclaving. A representative sampling of patents involving this design approach is provided by the following listed references:
______________________________________ Pat. No. Patentee Issue Date ______________________________________ 4,774,063 Runnells Sep. 27, 1988 4,959,199 Brewer Sep. 25, 1990 4,643,303 Arp et al. Feb. 17 1987 5,084,251 Thomas Jan. 28, 1992 4,854,475 Riihimaki, et al. Aug. 8, 1989 3,634,937 Green Jan. 18, 1972 3,285,409 Loran Nov. 15, 1966 ______________________________________
Another category of design approach involves the use of a plurality of holders whose positions are essentially fixed in the tray. The components, instruments and related apparata are then loaded into these fixed holders for autoclaving and safe storage after autoclaving. A representative sampling of patents following this second design approach category is provided by the following listed patent references:
______________________________________ Pat. No. Patentee Issue Date ______________________________________ 4,191,291 Brown Mar. 4, 1980 4,762,688 Berry Aug. 9, 1988 4,541,992 Jerge, et al. Sep. 17, 1985 4,253,830 Kazen Mar. 3, 1981 ______________________________________
As might be expected there is on occasion a patent reference which might arguably fit in both categories and from time to time patent references that might not easily fit into any general category. A representative sampling of these types of patents is provided by the following listed patent references:
______________________________________ Pat. No. Patentee Issue Date ______________________________________ 4,798,292 Hauze Jan. 17, 1989 4,353,694 Pelerin Oct. 12, 1982 5,098,676 Brooks, Jr. Mar. 24, 1992 ______________________________________
One of the drawbacks with almost any type of autoclave tray, case or enclosure when the style of the holders, brackets, racks and clamps are fixed or limited and when their positioning within the tray, case or enclosure is fixed or limited, is the lack of versatility and opportunity for customizing. With fixed designs there are no provisions made to allow for design freedom nor to enable the handling of unique and unusual items. Suppose a physician or dentist has a special instrument, possibly a custom made item for some unique procedure, how can it be handled by fixed-design holders and fixed positioning trays?
When trying to offer greater design freedom and flexibility there are other shortcomings which may be introduced that actually detract from the overall suitability of the new design. Consider for example the device disclosed in U.S. Pat. No. 5,098,676 wherein a fingermat is styled for an autoclave tray. Some of the key features to note regarding this reference include the fact that the fingermat has a size which completely covers and fills the bottom or floor of the corresponding tray. This particular design feature creates two other problems including first that any sterilant apertures which are formed or machined into the tray floor would initially be covered over by the fingermat. Secondly, there are potentially large areas of the fingermat which may in fact not be needed to receive and retain specific instruments or equipment and thus there is a cost inefficiency since the unused fingermat material will be wasted.
In order to try and solve the problem of covering or blocking sterilant apertures, the fingermat as disclosed in the '676 patent is provided with a plurality of flow apertures (34) and a total of 15 are illustrated. However, this pattern is predetermined and wherever flow apertures are located, the mat fingers must be removed and thus there is a corresponding loss of some of the design freedom. Further, since current design wisdom focuses on trying to create the maximum flow through and circulation of sterilant, it is desired to have more sterilant apertures rather than fewer. Obviously, the more that are introduced into the fingermat the fewer number of fingers and thus the less design freedom which is provided for arranging the items to be autoclaved.
Another reference to be considered in the sense of flexibility and design freedom is U.S. Pat. No. 4,762,688 wherein an autoclave tray is disclosed that uses a synthetic material holder to securely retain the medical instruments and components, while the extruded holder offers some design freedom because it can be customized by cutting and shaping, the receiving slots in the tray have fixed locations. The nomenclature on the top surface of the tray (see FIG. 2 of the '688 patent) indicates that the particular tray is intended for a predetermined and specific grouping of items, possibly a package that would correspond to one specific surgical procedure such as a total hip replacement. One of the features of the '688 patent is the use of a keyhole shaped entry aperture at one end of each receiving slot so that the base portion of the holder can slide into position and thereafter seat securely. It is also possible to remove the extruded holder by reversing the sequence of insertion steps. The holder base is continuous and it is relatively wide in comparison of the width of the receiving slot which is also continuous from the entry aperture to the closed end.
While the holder design flexibility and the mounting technique are clearly desirable features of this invention, the fixed layout and mounting pattern preclude having any design freedom as far as customizing the tray for a particular grouping of items in a particular pattern or arrangement. After studying and learning from the limitations of earlier designs, the present invention was conceived. The objective was to try and create an autoclave tray and holder combination which provides some of the desirable aspects of earlier concepts, but with greater flexibility for special layouts and customized arrangements, all at lower cost with higher reliability and all in a unique and unobvious package. The first step for this design evolution was to specifically target the key features and then see if it would be possible to provide all of those features without introducing any new shortcomings or problems.
The result of this design effort is the present invention which is disclosed herein. The design of the tray includes a uniform pattern of spaced sterilant apertures disposed throughout the surface of the tray so that there is an ample flow through of sterilant. These sterilant apertures double as receiving apertures for holders which are, in the preferred embodiment, flexible, silicone extrusions. These extruded holders can be provided in virtually any length and cut or shaped in virtually any manner with holes, notches, slots, etc. for receiving and holding some portion of a medical or dental instrument or component.
The tray layout can be predetermined and the holders created and installed by the manufacturer or the tray can be customized on site. The holder styles can be predetermined, standard holders can be offered, or the extruded holders can be customized on site. The tray and holder are compatibly configured such that the holder can be pushed into the tray apertures. However, once the holder is installed in the selected tray apertures, it will remain in position due to its own material properties including hardness and due in part to the nature of the interference fit between the base of the holder and the tray apertures. While removal of the holder from the aperture will likely damage the base of the holder, the extruded holders are relatively inexpensive and a new holder can be readily provided, modified as necessary and installed.
Each of these aspects of the present invention will be described in greater detail hereinafter, including a discussion of some of the unique benefits of the present design which would not be expected based upon earlier designs and current design concepts.